The Return of the Patent Cliff: Can Biopharma Keep Pace with Innovation?

The biopharmaceutical sector is once again confronting a significant wave of loss of exclusivity (LOE), echoing the “patent cliff” of the early 2010s. As key therapies such as Tagrisso (tagrisso patent expiration), Calquence (calquence patent expiry), and Olaparib (olaparib patent expiration) edge closer to the end of their patent protection, leading pharmaceutical companies are under pressure to act swiftly. This drug loss of exclusivity challenge spans both established and emerging markets—from the United States to regions like India and Japan (india loss of exclusivity analysis, japan loss of exclusivity analysis). Addressing this global shift requires sophisticated loss of exclusivity strategies to extend product lifecycle and maintain market dominance.

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Merck: Building Resilience Through Pipeline Strength

Merck is preparing for the inevitable generic competition to its top-selling Keytruda, prompting many to ask: when does Keytruda lose exclusivity? The company is countering this threat with a strong focus on pipeline-driven resilience. With significant investments in oncology and immunology, Merck is proactively managing its loss of exclusivity challenges. The recent introduction of Cobenfy, along with promising work in next-generation checkpoint inhibitors and vaccine innovation, highlights Merck’s strategic approach to navigating loss of exclusivity while securing long-term growth.

AstraZeneca: Science-Led Diversification for the Future

Facing upcoming LOEs for drugs such as Calquence and Tagrisso, AstraZeneca is leaning into a science-based diversification strategy. The company is expanding through focused research and development, strategic alliances, and new delivery formats—like the subcutaneous version of Enhertu. AstraZeneca’s approach to the pharma loss of exclusivity landscape involves bolstering its pipeline and engaging in mergers and acquisitions that support future therapies and reduce exposure to patent expiration shocks.

Bristol Myers Squibb: Managing Risk Through Cost-Conscious Innovation

With the Pomalyst loss of exclusivity on the horizon, Bristol Myers Squibb (BMS) is reinforcing its approach to cost-managed growth. The company’s strategy centers around careful reallocation of research and development resources, robust lifecycle planning, and global access initiatives. BMS is navigating the loss of exclusivity pharma challenge by preparing a next-generation portfolio that balances cost discipline with long-term innovation.

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Looking Ahead: A Call for Reinvention Over Reaction

The current LOE cycle requires more than reactive measures—it demands proactive transformation. Through deeper loss of exclusivity analysis, effective lifecycle extensions, and accelerated development of next-generation therapies, pharmaceutical companies are evolving their strategies. In this era of widespread drug loss of exclusivity, the keys to success are agility, focused investment, and scientific reinvention.